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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K915352
Device Name LASER FIBEROPTIC DELIVERY SYSTEM
Applicant
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Applicant Contact CHARLES L ROSE
Correspondent
Sunrise Technologies, Inc.
47257 Fremont Blvd.
Fremont,  CA  94538
Correspondent Contact CHARLES L ROSE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/26/1991
Decision Date 12/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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